Health Canada — Medical Devices · Canada · 2022-03-21 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Any pad currently installed in or stored with an HS1/onsite/home aed could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Recall start date: Mar 2, 2022
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